Currently, in the medical diagnosis field, in order to detect or quantify a particular sample contained in a bio-sample such as blood, serum, urine, and cell sap, various assay technologies such as enzyme assay, immunoassay, chemical colorimetric assay, electrochemical assay, fluorescence labeling and measurement, and chemiluminescent labeling and measurement are used. The assay technologies are applied and used in large apparatuses such as automatic assay devices used in clinical trial centers of hospitals, or point-of-care testing (POCT) devices using platforms such as test strips and cartridges.
The large automatic apparatuses have advantages in that a large quantity of samples can be treated at high speed and the reliability of measured values is high. However, there are disadvantages in that the mechanical structures of the apparatuses are complicated and the apparatuses can be used only in special examination rooms, which limit the number of locations in which they can be installed. Further, the apparatuses often require pretreatment of the bio-samples and periodic replacement of various types of reagents and sensors, thus making it very cumbersome to maintain and manage the apparatuses.
Meanwhile, in the case of the point-of-care testing device, the reliability of the measured values is rather low compared to those of the large apparatuses. However, the ability to take measurements is not limited in terms of location, and the measurement can be rapidly performed, which enables the POCT devices to be extensively used in the medical diagnosis field. Particularly, unlike the large apparatuses in which various types of reagents and sensors should be respectively equipped and installed, the cartridge-type point-of-care testing device constitutes a bio-sample supply unit, a reaction reagent, and a detection unit in one cartridge, thus providing high user convenience during measurement. Further, due to a low risk of contamination through exposure to the bio-sample after measurement, the device is favorable in terms of stability.
Meanwhile, for diagnosing diabetes, there is a growing demand for the point-of-care testing of glycated hemoglobin along with blood-sugar measurement. Glycated hemoglobin (HbAlc) refers to a hemoglobin bound to glucose. The measurement of glycated hemoglobin contained in blood not only provides an average blood-sugar value of a patient for the past three to four months regardless of meals and the physical state of the patient but also helps to evaluate the efficiency of the blood-sugar management method employed by the patient, thus drawing much public attention to the necessity of measuring glycated hemoglobin. In fact, numerous reports on cartridge-type point-of-care testing devices for measuring glycated hemoglobin contained in blood have been released.
U.S. Pat. No. 6,300,142 B1 discloses a cartridge for measuring an analyte by reacting a sample with a first reactant through a first inlet and subsequently reacting the sample with a second reactant through a second inlet in order to measure the glycated hemoglobin level in blood. However, in this case, measurements should sequentially occur at time intervals and a measurer should intervene in the measurement step to ensure that the samples can be sequentially injected to react. Further, there are problems in that a reagent solution may be leaked during the measurement process, thus deteriorating the reliability and marketability of the measurement result, and also that it requires pre-filtration of the beads combined with glycated hemoglobin, thus making the measurement complicated and require a longer time. Additionally, since the process requires direct intervention of a user in various steps, the user may feel encumbered, which naturally delays the measurement time.
Further, U.S. Pat. No. 7,632,462 B2 discloses an analysis cartridge including at least two well spaces and a pipette which may be positioned in at least the two well spaces. In this case, the pipette has a stylobate unit and an end unit, and the end unit has a structure which is closed by a membrane through which a liquid can permeate. Further, the patent discloses an assay device including a holder disposed to receive the cartridge, a driving unit operated to position the pipette in the selected well space in the cartridge, a gas pressure application device combined with the pipette to fluidize the liquid in the pipette through the membrane, a radiation detector detecting radiation from the well spaces or the pipette of the cartridge to be operated, and an electromagnetic radiation source. The assay device is a cartridge-type point-of-care testing device for glycated hemoglobin having a high quantitative property, but has disadvantages in that structures of the cartridge and the assay device are too complicated as described above to embody a driving system, thus increasing the cost of the assay device.
Accordingly, the present inventors developed a biochemical analysis cartridge including an insertion sample cartridge for supplying a bio-sample and a reaction cartridge including one or more reaction units capable of fixing one or more assay reagent and reacting the assay reagents with the solution reagent, and a measurement window capable of performing optical measurement, thereby completing the present invention.